Senior Clinical Data Science Lead

At ICON Strategic Solutions, you will work in a sponsor-dedicated model, supported by ICON’s global expertise. As the world’s largest FSP organisation, with over 90 sponsor partnerships, we offer stability, career development and a collaborative environment where your work contributes to the development of treatments that benefit patients worldwide.

What You Will Do:

• You will oversee clinical data management activities across the study lifecycle, ensuring deliverables meet quality, compliance, and timeline expectations.
• Key responsibilities include:
• Leading day-to-day clinical data management activities for assigned studies and providing oversight of CROs and external vendors, including laboratories, ECG providers, and imaging vendors.
• Monitoring vendor performance, timelines, and key performance indicators (KPIs), proactively identifying and mitigating data-related risks.
• Reviewing and approving study documentation, including Data Management Plans (DMPs), CRF/eCRF specifications, Data Validation Plans (DVPs), database specifications, and Data Transfer Agreements (DTAs).
• Participating in User Acceptance Testing (UAT) activities for Electronic Data Capture (EDC) systems and ensuring database functionality aligns with protocol requirements.
• Overseeing data quality review, reconciliation activities, query management, medical coding, safety data reconciliation, data cleaning, database lock readiness, and final data transfers.
• Managing clinical data management timelines to support key study milestones, including interim data cuts, analyses, and final database locks.
• Collaborating with cross-functional study teams and external partners to ensure compliance with ICH-GCP guidelines, FDA/EMA regulations, and applicable standard operating procedures.
• Leading study-related meetings with sponsors and vendors, maintaining clear communication and alignment across all stakeholders.

Your Profile:

You will have strong clinical data management experience, with the ability to manage multiple priorities, oversee external partners, and drive high-quality study delivery.

Required qualifications and experience:

• Bachelor's degree in a scientific, life sciences, healthcare-related, or equivalent discipline.
• Minimum of 5 years of clinical data management experience supporting multicentre clinical studies within the pharmaceutical, biotechnology, or CRO industry.
• Experience working in a sponsor environment or managing sponsor relationships through a CRO partnership model.
• Expertise with leading EDC platforms such as Medidata Rave, Oracle InForm, or Veeva Vault CDMS. Programming knowledge is desirable.
• Strong understanding of CDISC standards, medical coding dictionaries (MedDRA and WHO-DD), and data reconciliation processes.
• Deep knowledge of ICH-GCP guidelines, 21 CFR Part 11 requirements, and clinical data management best practices.
• Excellent communication, stakeholder management, and vendor oversight skills, with the ability to influence outcomes across cross-functional teams.
• Strong analytical and problem-solving abilities, with a track record of identifying and resolving complex data issues and study risks.
• Previous experience supporting tobacco or nicotine-related clinical studies and knowledge of EU clinical regulations would be an advantage.
• Fluent English language skills, both written and verbal.

Rewards & Benefits

ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development. Benefits may include:

• Competitive base salary and performance related incentives
• Health and wellbeing programmes including medical, dental, and vision coverage where applicable
• Retirement and pension plans
• Life assurance and disability coverage
• Employee assistance programmes and wellbeing resources
• Learning and development opportunities through structured training and career pathways

Benefits may vary depending on role and location. Visit our careers site to read more about the benefits ICON offers.

Inclusion and Accessibility

ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported. If you require reasonable accommodations during the recruitment process, please let us know or submit a request here.